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SAME DAY ART INITIATION. JUNE 2019 Page 1 of 15
Kingdom of Cambodia
Nation Religion King
Ministry of Health
Concept Note on
The Same Day ART Initiation in Cambodia
National Center for HIV/AIDS, Dermatology and STD
June 2019
SAME DAY ART INITIATION. JUNE 2019 Page 2 of 15
Acknowledgement
On behalf of NCHADS, I would like to express my sincere appreciation and gratitude to all who
contributed to the development of this concept-note such as technical staff of NCHADS and
development partners LINKAGES/FHI360, US-CDC, UNAID, WHO, KHANA, CHAI, CRS,
CPN+, AHF and AUA who dedicated their valuable time and efforts to provide inputs and
successfully create this important document.
NCHADS also would like to special thanks to Dr. Samreth Sovannarith, Chief of Technical Bureau
of NCHADS, Dr. Ngauv Bora, Deputy Chief of Technical Bureau of NCHADS, Dr. Chan Sodara,
Public Health Specialist of US-CDC, Dr. Chel Sarim, Program Specialist HIV/AIDS of
LINKAGES, Dr. Steve Wignall, Project Director of LINAKGES and Mr. Im Chanry, Strategic
Information Technical Advisor of LINKAGES Project. who have drafted this concept note.
Phnom Penh, ……../………/ 2019
Dr. Ly Penh Sun
Director, NCHADS
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Contents
Acknowledgement ..................................................................................................................................................... 2
Abbreviations ............................................................................................................................................................... 4
List of contributors to the development of this concept note ...................................................................... 5
I. Background and rationale ............................................................................................................................... 6
II. Objectives ........................................................................................................................................................ 7
III. Definition of same day ART initiation .................................................................................................. 7
IV. Eligibility for same day ART initiation ................................................................................................. 7
V. Reasons for possible non-eligibility for same day ART initiation ............................................... 7
VI. Process of the same day ART initiation ................................................................................................ 8
6.1 Patient flow at ART clinic ..................................................................................................................... 8
6.2 Clinical Assessment: ............................................................................................................................... 9
6.3 Counseling: ................................................................................................................................................. 9
6.4 Laboratory: ................................................................................................................................................. 9
VII. ARV regimen ................................................................................................................................................. 9
VIII. Follow up ................................................................................................................................................. 10
IX. Monitoring .................................................................................................................................................... 11
X. References .................................................................................................................................................... 15
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Abbreviations
3TC Lamivudine
ART Antiretroviral Therapy
ARV Antiretroviral
CBC Complete Blood Count
CI Confidence Interval
CTX Cotrimoxazole Prophylaxis
DTG Dolutegravir
HBV Hepatitis B virus
HCV Hepatitis
HIV Human Immunodeficiency Virus
EFV Efavirenz
OI Opportunistic Infection
PCP Pneumocystis Carinii Pneumonia
PEP Post Exposure Prophylaxis
PI Protease Inhibiter
PrEP Pre-Exposure Prophylaxis
PLHIV People Living with HIV
RNA Ribonucleic Acid
TDF Tenofovir
TPT Tuberculosis Prevention Therapy
UNAIDS United Nations Programme on HIV and AIDS
VCCT Voluntary Confidential Counseling and Testing
WHO World Health Organization
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List of contributors to the development of this concept note
Dr. Ly Penh Sun Director, NCHADS
Dr. Samreth Sovannarith Chief, Technical Bureau, NCHADS
Dr. Ngauv Bora Deputy Chief, Technical Bureau, NCHADS
Dr. Chan Sodara Public Health Specialist of HIV/AIDS, US-CDC
Dr. Steve Wignall Project Director, FHI360/LINKAGES
Mr. Im Chanry Strategic Information Technical Advisor, FHI360/LINKAGES
Dr. Chel Sarim Program Specialist HIV/AIDS, FHI360/LINKAGES
SAME DAY ART INITIATION. JUNE 2019 Page 6 of 15
I. Background and rationale
The Cambodian National HIV Clinical Management Guidelines, adapted from WHO guidelines
aim to provide better and more effective care to PLHIV in Cambodia. Cambodia has successfully
implemented the “treat all” WHO recommendation of 2018 with most individuals testing HIV
positive promptly starting anti-retroviral treatment (ART).
In July 2017, WHO issued guidelines for rapid initiation of antiretroviral therapy that states
“Rapid ART initiation should be offered to all people living with HIV following a confirmed
HIV diagnosis and clinical assessment”. Rapid initiation is defined as within seven days from the
day of HIV diagnosis; people with advanced HIV disease should be given priority for assessment
and initiation. Furthermore, the guidelines recommend ART initiation should be offered on the
same day to people who are ready to start.
There are several studies showing the benefits of rapid or same-day ART. In a study by Rosen S
showed that those randomized to receive immediate ART on the day of diagnosis were
significantly more likely than those randomized to usual care (three to five additional visits with
adherence counseling over 2 to 4 weeks prior to ART initiation) to be virally suppressed at 10
months (64% vs. 51%). In the rapid arm, 119/187 patients (64%) initiated treatment and were
virally suppressed at 10 months, compared to 96/190 (51%) in the standard arm (relative risk
[RR] 1.26 [1.05-1.50]).
Similar improvements in both the proportion of participants retained in care achieving viral
suppression and survival at the end of 1 year were recently reported in a randomized controlled
trial of same-day ART initiation conducted in Haiti. The unadjusted risk ratio (RR) of being
retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015)
for the same-day ART group compared to the standard ART group, and the unadjusted RR for
being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012).
However, a study conducted by Chan AK, Kanike E, Bedell R, et al in Malawi, showed that after
ART initiation, a greater proportion of people were lost to follow-up in the same-day start group,
although the trial sample size was small and differences were not significant. In Malawi, same-
day ART initiation in pregnant women with HIV was associated with reduced retention, because
many women reportedly struggled with initiating ART on the same day as learning their HIV
status
Another study by Pilcher, et al. concluded that the treatment for HIV infection can be started on
the day of diagnosis without impacting the safety or acceptability of ART. Same-day ART may
shorten the time to virologic suppression.
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Treating HIV early can help keep level of viral load low and protecting the patients’ health by
preserving immune function and reducing the risk for severe opportunistic infections. For
patients rapid ART or same-day ART will help them:
- Stay healthier longer by preserving the immune system by maintaining high CD4 cell
counts
- Reducing risk of opportunistic infections and other diseases,
- Reducing or nearly eliminating the chance of transmitting HIV to other people
- Increasing access to other services they need such as social support, addiction recovery,
and mental health.
II. Objectives
The main objectives of this document are:
▪ To provide the public health and HIV program rationale for rapid or same-day ART,
▪ To provide a practical guide for ART teams, HIV care related team, and planning team
for rapid or same-day ART implementation.
III. Definition of same day ART initiation
Initiation ART at ART clinic on the same day of HIV confirmation at VCCT for adolescents
and adults who are no contraindication to the criteria of the same day ART initiation.
IV. Eligibility for same day ART initiation
Anyone with a new confirmed HIV diagnosis:
- New HIV infected adolescents and adults enrolled in ART clinic
- No experience using ART, except ARV prophylaxis such as PEP, PrEP and PMTCT.
- Asymptomatic infection
- No use of nephrotoxic drugs
- No history of renal failure
V. Reasons for possible non-eligibility for same day ART initiation
Patients for whom the same day ART might be medically complicated and need prior well
managed active opportunistic infection before initiating ART1 .
1 Please refer to Table 8-3 page 53 in current National HIV Clincial Management guideline for Adult and adolescent 2015.
SAME DAY ART INITIATION. JUNE 2019 Page 8 of 15
- TB symptoms or TB screen positive
- Suspected PCP, cryptococcal meningitis or other severe OIs
- Patient had experience on ART for HIV/AIDS
- Use of nephrotoxic drugs
- Patient with drug use, high toxicity and could not provide counseling
Note: If the patient presents with one or more risk factors above, a blood test for serum
creatinine levels and calculate the creatinine clearance. Only initiate patients to TDF if
creatinine clearance is equal or greater than 60 ml/min.
VI. Process of the same day ART initiation
6.1 Patient flow at ART clinic
First Visit at ART Clinic (First Enrollment) VCCT: HIV confirmation test positive
Triage: - create new patient file
- Link to UUIC
Counselor: - Counseling about HIV
prevention, care and treatment
- ART preparation
- Adherence, partner testing
Clinician: Clinical Assessment:
- History/exam
- TB symptom screening
- Other OIs screening
Eligible for same day ART initiation: - Asymptomatic patient
Started same day ART initiation (Confirm HIV test again at VCCT) Follow up for one week
Follow the national HIV clinical management guidelines for Adults and Adolescents 2015 for starting ART
Laboratory: Baseline lab test: creatinine, CBC, LFT, HBV, HCV and CD4
Pharmacy: Taking ARV drugs and other medicines as in the prescription
Yes No
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6.2 Clinical Assessment:
▪ History/exam to assess for OI’s (TB symptom screening, PCP, meningitis and
other OIs)
▪ If asymptomatic and no contraindication to same day ART initiation, then okay to
start same day ART
6.3 Counseling:
Drug counselor at ART clinic provides counseling on the benefit of the same day ART
treatment, important of adherence, family planning, partner testing, HIV prevention,
care and treatment and ART preparation including explanation of possible side-effects.
Female patients of childbearing age who will be taking dolutegravir (DTG) will need
a pregnancy test and counseling on effective and adhere to family planning methods.
If she is pregnant or desires to get pregnant, non-DTG containing regimens should be
offered.
6.4 Laboratory:
Nurse takes blood from the patient for baseline lab test, creatinine, CBC, liver function
test, HBV, HCV test and CD4 count. Female patients of child bearing age need to be
checked for pregnancy before starting. The cryptococcal antigen test will be done at
laboratory if CD4 count of the patient ≤100 cell/mm3. Patients can be contacted and
return to clinic based on laboratory results.
VII. ARV regimen
The preferred first-line regimen for nearly all populations are: TDF+3TC+DTG*
Population Preferred Alternatives**
Adult men and adolescent boys
TDF+3TC+DTG
TDF+3TC+EFV600
TDF+3TC+EFV400
Pregnant (> 8 weeks after conception)
and breastfeeding women and
adolescent girls
Women and adolescent girls using
effective contraception or not of
childbearing potential
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Women and adolescent girls of
childbearing potential who want to
become pregnant or are not effective
contraception
TDF+3TC+EFV600
TDF+3TC+EFV400
TDF+3TC+PI
*More detailed information about DTG use, see operational guidance: Use of Dolutegravir
(DTG) for adults and adolescents in Cambodia, December 2018.
**For special situations, ARV side effect, renal insufficiency, see in detail in the National HIV
Clinical Management Guidelines for Adults and Adolescents, Chapter 10. Monitoring and
Substitutions for ART Toxicity, page 57.
VIII. Follow up
Clinicians have to make sure that the next follow-up visit is in accordance with the follow-up
schedule below.
Day/week Clinical Adherence
counseling
Laboratory Drugs
Day 0 × × × Start ART
Start CTX
Week 1 (7 days
after first visit)
× × See result Stop CTX if CD4 ≥ 350.
Start Fluconazole prophylaxis
if indicated based on CD4.
Week 2 × × Start TB preventive therapy
(TPT) if clinically screen
negative for active TB and
there is no contra-indication to
start TPT2
Follow up every month for TPT.
TPT guidelines and SOP is being updated and treatment regiments can be either of Rifapentine
and isoniazid weekly for 3 months (3HP) or Rifampicin plus isoniazid daily for 3 months (3HR)
to be offered as alternative to current Isoniazid monotherapy for 6 months (6H).
2 Refer to Chapter 6 table 6.2 page 46 of National HIV clinical management guidelines for adults and adolescent ,2015
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When patient has finished TPT but still on CTX prophylaxis, see the National HIV
Clinical Management Guidelines for Adults and Adolescents, Table 2-1 Clinic visit
routine schedule on page 29 and for routine laboratory investigation see Table 2-3
Routine Laboratory investigation on page 30 (English version).
IX. Monitoring
To ensure the program is collecting, documenting and reviewing necessary data to see the
progress of the same-day ART, indicators below will be monitored.
Indicator 1: Percentage of patients initiating same-day ART s
Indicator 2: Percentage of patients who come for follow-up visit as scheduled
Indicator 3: Percentage of patients have VL results suppression at the first 6 months
Indicator 4: Percentage of patients who retained on ART at 12 months
Indicator 5: Percentage of patients lost to follow-up after ART initiation
Indicator 6: Percentage of patients were stopped ART treatment because of ARV side
effect
Indicator 1: Percentage of patients have same-day ART initiation
Definition Number ART patients who have ART initiated on the same day as
their HIV confirmatory test divided by the total number of patients
enrolled at the ART clinic in the reporting period.
Purpose To measure the percentage of same-day ART initiation.
Method of
Measurement
Count the number of patients who have ART initiation date the same
as HIV confirmatory test date, then compute for percentage using
numerator and denominator below.
Frequency Monthly
Numerator Number ART patients who have ART initiation date the same as
HIV confirmatory date in the reporting period.
Denominator Total number of patients enrolled at the ART clinic in the reporting
period.
Disaggregation(s) Same Day ART Initiation (0 day)
Not Same Day ART Initiation
Source of data ART database
Interpretation Of the total patient load, how many clients have initiated same-day
ART?
Indicator 2: Percentage of same day initiation patients who come for follow-up visits as
scheduled
Definition Number same-day ART initiation patients who came for follow-up visit
as scheduled divided by the total number of same-day ART initiation
patients enrolled at the ART clinic.
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Purpose To measure the “discipline” of same-day ART initiation patients.
Method of
Measurement
Count the number of patients who have same-day ART initiation and
came for the follow-up visit as scheduled, then compute for percentage
using numerator and denominator below.
Frequency Monthly
Numerator Number of same-day ART initiation patients who came for follow-up as
scheduled in the reporting period.
Denominator Total number of same-day ART initiation patients enrolled at the ART
clinic in the reporting period.
Disaggregation(s): Early
On the schedule
Within buffer (1-5 days)
Beyond the buffer (> 5 days)
NCHADS: “drug buffer is never more than 5 days”
Source of data ART database.
Interpretation How “disciplined” are same day initiation patients?
Indicator 3: Percentage of patients have viral load suppressed at month 6th (From month 5
through month 7) after ART initiation
Definition Number of patients with viral load suppression after 6 months of ART
divided by the total number of patients initiating ART for the same
period.
Purpose To monitor the efficacy of ART treatment among same-day (rapid)
ART initiation patients.
Method of
Measurement
Count number of patients at the ART site in the reporting period who
have been initiated ART in the past six months (From month 5 through
month 7), then compute for percentage using numerator and
denominator below.
Frequency Six months
Numerator Number of patients who have viral load suppression 6 months after
the same day ART initiation (within 210 days).
Denominator Total number of patients initiating ART the same day at the site during the
same period.
Disaggregation(s) Same Day ART Initiation (0 day)
Not Same Day ART Initiation
Source of data ART database
Interpretation What is the difference between viral load suppression rate among
same-day (rapid) and non-rapid ART initiation?
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Indicator 4: Percentage of patients who retained on ART at 12 months
Definition Number of patients who are still active (on ART in the clinic) after 12
months of ART initiation divided by the total number of patients
initiating ART in the 12 months prior the reporting period.
Purpose To monitor the proportion of HIV infected patients on ART and
actively followed by ART clinics.
Method of
Measurement
Count number of registered patients at the ART site 12 months prior
the beginning of reporting period, count number of active patients,
dead, and lost to follow-up, then compute for percentage using
numerator and denominator below.
Frequency Annually
Numerator Number of patients who are still receiving ART during the selected
12 months after ART initiation (excluding those who were lost-to-
follow-up, died, and transferred out).
Denominator Total number of patients initiating ART in the 12 months prior to the
beginning of the current reporting period (including those who were
transferred in)
Disaggregation(s) Same Day ART Initiation (0 day)
Not Same Day ART Initiation
Source of data ART database
Interpretation Is the retention rate among rapid ART initiation clients less, equal or
greater than the retention rate among not SD/Rapid ART initiation?
Indicator 5: Percentage of patients lost to follow-up after ART initiation
Definition Number of patients who are lost to follow-up divided by total number
of patients on ART (active patients + LTF + died + transfer out) at the end
of the reporting period
Purpose To monitor the proportion of HIV infected patients on ART and
actively followed up by ART clinics.
Method of
Measurement
Count number of registered patients at the ART site in the reporting
period who have received ART, then compute for percentage using
numerator and denominator below.
Frequency Quarterly
Numerator Total number of patients who were lost to follow up during the
reporting period.
“Lost to follow up” is defined by the NCHADS patients who did
not come for the visit at ART site more than 90 days after missing
the “next appointment” date.
Denominator Total number of patients on ART at the end of the reporting period
(active patients + LTF + died + transfer out)
Disaggregation(s) Same Day ART Initiation (0 day)
Not Same Day ART Initiation
SAME DAY ART INITIATION. JUNE 2019 Page 14 of 15
Source of data ART database
Patient register
Interpretation Is the lost to follow-up rate among same day (SD) ART initiation less,
equal or greater than the lost to follow-up rate among not SD ART
initiation?
Indicator 6: Percentage of patients were stopped ART treatment because of ARV side effect
Definition Number of patients who started same day ART then stop at least one
drug due to side effects divided by total number of patients started
same day ART in the reporting period.
Purpose To monitor the proportion of HIV patients stop ART treatment due to
side effects of the drugs.
Method of
Measurement
Count number of registered patients started same day ART in the
reporting period then compute for percentage using numerator and
denominator below.
Frequency Quarterly
Numerator Patient who start same day ART then stop at least one drug because of
side effect during the reporting period.
Denominator Total number of patients start same day ART in the reporting period
Disaggregation(s) Same Day ART Initiation (0 day)
Not Same Day ART Initiation
Source of data ART database
Patient register
Interpretation Is the rate of stopping treatment among SD ART initiation less, equal
or greater than the stopping treatment rate among not SD ART
initiation?
SAME DAY ART INITIATION. JUNE 2019 Page 15 of 15
X. References
The Cambodian National HIV Clinical Management Guidelines, 4th revision in 2015.
Rosen S, Maskew M, Fox MP, et al. Initiating antiretroviral therapy for HIV at a patient's
first clinic visit: The RapIT randomized controlled trial. PLoS
medicine. 2016;13(5):e1002015. Available
at: https://www.ncbi.nlm.nih.gov/pubmed/27163694.
Koenig SP, Dorvil N, Devieux JG, et al. Same-day HIV testing with initiation of
antiretroviral therapy versus standard care for persons living with HIV: A randomized
unblinded trial. PLoS medicine. 2017;14(7): e1002357. Available
at: https://www.ncbi.nlm.nih.gov/pubmed/28742880.
Chan AK, Kanike E, Bedell R, et al. Same day HIV diagnosis and antiretroviral therapy
initiation affects retention in Option B+ prevention of mother-to-child transmission
services at antenatal care in Zomba District, Malawi. J Int AIDS Soc. 2016; 19: 20672
Katirayi L, Namadingo H, Phiri M, et al. HIV-positive pregnant and postpartum women's
perspectives about Option B+ in Malawi: a qualitative study. J Int AIDS
Soc. 2016; 19: 20919
Pilcher CD, et al. The Effect of Same-Day Observed Initiation of Antiretroviral Therapy
on HIV Viral Load and Treatment Outcomes in a US Public Health Setting. J Acquir
Immune Defic Syndr. 2017 Jan 1;74(1):44-51
The New England Journal of Medicine. Initiation of Antiretroviral Therapy in Early
Asymptomatic HIV Infection. Available at
https://www.nejm.org/doi/pdf/10.1056/NEJMoa1506816
WHO. Guidelines for Managing Advanced HIV Disease and Rapid Initiation of
Antiretroviral Therapy. July 2017.